APPLICATION FOR NOTIFICATION OF EXPORT ONLY MEDICAL DEVICE

APPLICATION FOR NOTIFICATION OF EXPORT ONLY MEDICAL DEVICE

The importation, exportation, or placement of a medical device in the Malaysia market requires the medical device to be registered under Medical Device Act 2012 (Act 737). The Circular Letter of Medical Device Authority No. 4 Year 2018 exempts medical devices that are for export only from registration requirements and only require notification to the Authority.

An “Acknowledgement on Notification” letter issued by MDA then permits the device to be exported.

All information and related forms can be download as below:

GUIDANCE DOCUMENT: NOTIFICATION OF EXPORT ONLY MEDICAL DEVICE – Click Here

APPLICATION FOR NOTIFICATION OF EXPORT ONLY MEDICAL DEVICE – Click Here

EFFECTIVE DATE START ON 16 JULY 2019

Medical Device Authority (MDA),

Ministry of Health Malaysia,

Level 6, Prima 9, Prima Avenue II,

Block 3547, Persiaran APEC,

63000 Cyberjaya, Selangor, MALAYSIA

Tel: +603 - 8230 0300/ Fax: +603 - 8230 0200

 mdb@mda.gov.my / exportonly@mda.gov.my